Heart failure (HF) exacerbations increase mortality risk and lower quality of life (QOL). Diet and drug therapy are crucial in lowering HF exacerbations. Though the efficacy of appropriate treatment in lowering mortality and improving QOL is established, a significant gap exists between ideal treatment and actual practice. Insufficient treatment adherence is a major reason for HF exacerbations. We conducted a pilot 3-arm randomized controlled trial (RCT) to assess two novel interventions in HF targeting medication adherence and QOL. There were two active phone intervention arms: one active arm that included a patient-based Transtheoretical model (TTM) intervention and the other arm that included the patient-based TTM intervention with additional tailoring on the built and human environment. The control group was VHA current standard of care with attention to blinding that we call current best practice rather than placebo.
The overarching hypothesis driving this study is that a comprehensive behavioral intervention (BI) or a behavioral and environmental intervention (BEI) would lower HF recurrence and improve QOL through improved adherence compared to Current Best Practice (CBP). The primary aim was to evaluate the effect of BI and BEI on medication adherence after 6 months. Secondary outcomes included HF-related and general QOL, diet adherence, intervention satisfaction and acceptability. We hypothesized that BI and BEI would have better outcomes compared to CBP. The study provides preliminary data to evaluate if a future Service Directed Project is warranted to rigorously test the effectiveness of BI and BEI.
This was a 3-arm RCT in two VAMC's with outcomes measured at the patient level at baseline and 6 months. The study was embedded in typical VA healthcare with all 3 arms incorporating the enhancements in HF care that have been implemented including the Patient Aligned Care Teams (PACT), system redesign methods to improve HF care, ongoing HF quality improvement and Telehealth. In addition to this background HF care, a) BI received monthly calls based on TTM with counseling tailored to stage of change (SOC) on decisional balance, self-efficacy, and barriers and facilitators of HF care, b) BEI received the BI components with built environment tailoring [in relation to diet and physical activity] and human environment tailoring [caregiver intervention] and, c) In an attempt to blinding, CBP received phone counseling for various non-cardiovascular healthful behaviors such as colorectal cancer screening, vaccinations, dental hygiene, sleep hygiene, vision care, and memory maintenance. Participants were veterans with NYHA classes I-III HF with prescribed beta blockers and ACEI/ARB therapy for 6 months. Exclusion criteria included poor short term survival, recent major surgery, severe psychiatric illness and other logistic and discretionary reasons. The primary outcome, medication adherence was measured from the VA pharmacy database (refill compliance). QOL was measured using the general SF-36V and the disease-specific Minnesota Living with Heart Failure Questionnaire (MLHFQ). Other measures were assessed by either validated instruments from the field or those that were developed in previous research studies from our research group. Unadjusted evaluations of discrete/categorical variables were conducted by Fisher's Exact Test. Wilcoxon rank-sum test was used for continuous variables. All analyses were intent to treat.
We enrolled 99 participants - 33 in each of the three arms. Overall, the response rate at 6-month follow-up was 86.9% with (BI: 81.8%, BEI: 87.9%, CBP: 90.9%). The average age was 68.7 years, 99.0% were male, 44.4% were white, 36.36% Black/African American, 90.9% had more than 12 years education, 33.3% were currently married, and 49.49% lived alone. The only demographic variables that were statistically significant between the three arms were: currently married (BI: 24.4%, BEI: 51.5%, CBP: 24.4%) and living alone (BI: 45.5%, BEI: 30.3%, CBP: 72.7%). Baseline mean average refill compliance for all HF medication was already very high (BI: 0.90, BEI: 0.86, CBP: 0.91) and there was very minimal increase at follow-up (BI: 90%, BEI: 87%, CBP: 92%). For medication SOC, all patients reported being in the action or maintenance stage. General mean QOL scores, as measured by the SF-36 with higher values representing better QOL, were: physical component (BI: 37.7, BEI: 35.9, CBP: 39.3) and mental component (BI: 44.3, BEI: 48.4, CBP: 51.3). The comparison for disease-specific QOL, measured using the MLHFQ with lower scores representing better QOL were: overall (BI: 32.7, BEI: 31.8, CBP: 26.7), physical dimension (BI: 14.6, BEI: 16.1, CBP: 12.9), and emotional dimension (BI: 7.0, BEI: 6.7, CBP: 6.3). BEI had the most improvement in the change in disease-specific QOL score for overall (BI: -0.74, BEI: -10.00, CBP: -0.57) physical (BI: -1.22, BEI: -3.50, CBP: +0.30) and emotional (BI: +0.04, BEI: -2.31, CBP: -0.33). More patients in BEI (75.0%) reported being in action and maintenance for diet SOC than BI (63.0%) and CBP (65.5%). Overall, 56.6% received all 6 monthly calls, 68.7 % received at least 5 monthly calls and 77.1 % received at least 4 monthly calls. Approximately 60.6% from CBP received all 6 calls compared to 57.6% and 51.5% from BEI and BI, respectively. None of the results reported were statistically different between the three arms.
The primary outcome, medication adherence (assessed by refill compliance) was very high at baseline in all three arms, which resulted in very minimal and non-significant increase in adherence at follow-up. BEI reported most improvement for disease-specific QOL and diet SOC. However, for most other outcomes, the results were not statistically different across the three arms.
None at this time.
Treatment - Comparative Effectiveness